Naglazyme
Naglazyme (galsulfase) treats a rare condition called Mucopolysaccharidosis VI (or Maroteaux-Lamy syndrome). It's given as an infusion into the veins by a healthcare provider, so it's not a medication you can pick up at the pharmacy. This medication can cause reactions during or after the infusion including fever, chills, trouble breathing, and nausea.
What is Naglazyme (galsulfase)?
What is Naglazyme (galsulfase) used for?
Improve the ability of people with Mucopolysaccharidosis VI to walk and climb stairs
How Naglazyme (galsulfase) works
Naglazyme (galsulfase) is an enzyme replacement therapy (ERT), which means that it replaces an enzyme (protein) in your body. People with Mucopolysaccharidosis VI either don't have any or don't have enough of an enzyme that breaks down a certain sugar called glycosaminoglycan (GAG). GAG builds up in your body over time and can cause symptoms, such as bone changes, vision changes, and heart problems. Naglazyme (galsulfase) replaces the missing enzyme that breaks down the sugars, providing relief from some symptoms of Mucopolysaccharidosis VI.
Drug Facts
What are the side effects of Naglazyme (galsulfase)?
Common Side Effects
- Infusion-related reactions (e.g., fever, chills, rash, trouble breathing, nausea; 56%)
- Stomach pain (47%)
- Joint pain (42%)
- Ear pain (42%)
- Pain (32%)
- Rash (21%)
- Pink eye (conjunctivitis) (21%)
- Chills (21%)
- Difficulty breathing (21%)
Other Side Effects
- Headache
- Nausea
- Vomiting
- Fever
- Itchy skin
- Chest pain
- Sore throat
- Stuffy nose
- Hearing problems
Serious Side Effects
- Serious allergic reactions: swelling of the face, throat or tongue, wheezing, hives, rash, flushing, vomiting, trouble breathing
Source:Â DailyMed
The following side effects have also been reported
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:
Less common
Blurred or decreased vision
difficult or labored breathing
dizziness
headache
hernia of the naval
nervousness
pounding in the ears
slow or fast heartbeat
swelling of the face
tightness in the chest
Incidence not known
Back pain
bluish lips or skin
confusion
dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
fever, chills, or sweating
hives or welts
joint pain
large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
loss of bladder control
loss of bowel control
nausea or vomiting
paralysis of the limbs
stomach pain
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Less common
Body aches or pain
burning, dry, or itching eyes
congestion
dryness or soreness of the throat
excessive tearing
loss of or increase in reflexes
runny or stuffy nose
tender, swollen glands in the neck
trouble with swallowing
unusual tiredness or weakness
voice changes
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Pros and cons of Naglazyme (galsulfase)
Pros
The only medication FDA-approved for people with Mucopolysaccharidosis VI
Helps you walk farther and climb more stairs than before
Can possibly receive the infusion in your home if your provider thinks it's safe for you
Works well and is safe when used long-term
Cons
Commonly causes infusion-related side effects (e.g., chills, itchy skin, and headache)
Infusion takes at least four hours
Only available as a brand medication so it can be expensive
Requires IV access, so it's not as convenient as taking a pill
Pharmacist tips for Naglazyme (galsulfase)
Your infusion will take at least 4 hours to receive the full dose of Naglazyme (galsulfase). It can take longer depending on how well you tolerate the infusion. If you tolerate it well, you might be able to receive your dose at home. Talk to your provider to see if this is an option for you.
Stay on track with your infusions, even if you start to feel better. Naglazyme (galsulfase) will help make sure that glycosaminoglycan (GAG) doesn’t start to build up in your body again causing your symptoms to come back. If you miss a dose, be sure to reschedule your infusion right away.
If you have sleep apnea and use oxygen or a continuous positive airway pressure (CPAP) machine, bring it with you to your infusion. Your provider might also give you diphenhydramine (Benadryl) before your infusion that might make you sleepy. Bringing your oxygen or CPAP machine can be helpful if you have an infusion reaction or get too sleepy during your infusion.
Naglazyme (galsulfase) can cause infusion-related symptoms, such as feeling hot, itchy skin, headache, or nausea. Tell your provider if you're not feeling well during your infusion. They might give you medications like acetaminophen (Tylenol) or diphenhydramine (Benadryl) to help relieve these symptoms.
Serious allergic reactions (e.g., trouble breathing, hives, vomiting, or swelling of the face, throat, or tongue) might happen during or up to 24 hours after your Naglazyme (galsulfase) infusion. Let your provider know if you start to have these symptoms so that you can be treated immediately.
Frequently asked questions about Naglazyme (galsulfase)
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What are the risks and warnings for Naglazyme (galsulfase)?
Naglazyme (galsulfase) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Serious allergic reactions
Serious allergic reactions to Naglazyme (galsulfase) are possible. These reactions can include life-threatening problems like anaphylaxis (closing of the throat and difficulty breathing) and lower blood pressure. These reactions can happen during your infusion or up to 24 hours after your infusion has finished. Tell your provider right away if you begin to experience any of these symptoms during treatment. Your provider might stop the infusion and give you medications to help the symptoms go away. Your provider will decide if you should continue to receive Naglazyme (galsulfase).
Infusion-related reactions
Your provider might give you medications before your Naglazyme (galsulfase) infusion to help avoid infusion-related reactions. Let your provider know if you start to feel unwell at any point during the infusion or after you receive treatment. In clinical studies, over half of people experienced infusion-related reactions, including fever, chills, rash, nausea, vomiting, and trouble breathing. And these reactions happened anytime from the first infusion up to almost 3 years later.
If any of these reactions occur, your provider can adjust the infusion rate, temporarily stop the infusion, or give you medications to manage your symptoms. This might also mean you need to have medication before your next infusion to prevent or lessen the severity of these symptoms. If you've previously had an infusion-related reaction, your provider probably will want to observe you for a little while to see how you respond to the infusion in case they need to give you appropriate treatment.
Immune system reactions
People can experience abnormal immune system reactions after enzyme replacement therapies like Naglazyme (galsulfase). These reactions cause parts of your body, like your kidneys, to become inflamed and damaged. This type of reaction, which typically happens after you have received at least one infusion, might not occur very quickly and can take several days to develop. Symptoms of these reactions can include fever, weight loss, or fatigue. If you have an immune system reaction, your provider will decide if you should continue receiving Naglazyme (galsulfase) infusions.
Heart or lung problems during infusion
Risk factors: Weighing 44 pounds or less | Heart or lung problems | Sleep apnea | Having a fever
People who have certain heart or lung problems are at higher risk for experiencing serious breathing problems when receiving a Naglazyme (galsulfase) infusion. Your provider might want to monitor you for longer to make sure you tolerate the infusion. Also if you have sleep apnea, remember to bring your oxygen or CPAP machine. Tell your provider immediately if you experience any chest pain, have trouble breathing, or feel too sleepy during your infusion.
Spinal cord damage
Spinal or cervical cord compression (SCC) can naturally occur in people with Mucopolysaccharidosis VI. But it's possible that Naglazyme (galsulfase) might cause SCC to happen quicker or become worse and require surgery. This is when your spinal or cervical cord is being compressed (or squeezed), which can lead to loss of feelings or nerve function in certain parts of your body. Let your provider know if you start having more back pain, loss of feeling in arms or legs, or you are not able to control when you need to go to the bathroom.
Naglazyme (galsulfase) dosage forms
Typical dosing for Naglazyme (galsulfase)
Naglazyme (galsulfase) is given as an infusion into your veins (intravenous or IV) by a healthcare provider. The dose is based on your body weight.
The typical dose is 1 mg/kg once a week given IV.
Interactions between Naglazyme (galsulfase) and other drugs
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
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